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Job Details: Inspection Readiness Expert

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Inspection Readiness Expert
Fixed Term Contract(FT)
US - Home Based
The Inspection Readiness Lead provides crucial TMF oversight in collaboration with QA to ensure Inspection Readiness for TMF Portfolio.
  • Collaborate with current TMF Advisor on process improvement and TMF-Quality Oversight
  • Liaise with relevant functional leaders regarding responses to audits, inspections and CAPA management associated to TMFs and the management process
  • Support inspections and audits, including preparedness and being a point of contact for TMF related questions across the portfolio
  • Ensure eTMF specifications for the project are compliant and consistent with program strategy, company standards, and applicable regulatory requirements and guidance
  • Provide guidance, clarification, and strategy for regulatory requirements and compliance
  • Support study team in addressing/reporting regulatory queries pertaining to document management.
  • Conducts gap analysis and develops plans to address deficiencies, may facilitate implementation of plan as well
  • Advises on industry trends and regulatory changes that may affect TMF management,
  • Designs and develops training, SOPs, and other guidance documents needed to support management of TMF activities
  • Process & Compliance
  • Workstream support
  • Logistics and meeting that support study team deliverables for Inspections
  • Collaboration with TMF team for IR support activities
Required Skills & Experience
  • Minimum 5 years of relevant experience in Clinical or TMF Operations oversight
  • Experience working with QA department
  • Experience in regulatory agency inspections
  • Demonstrated awareness of sponsor oversight and TMF
  • Experience in management of medical/clinical study records and documentation.
  • Experience/knowledge of ICH/GCP documentation requirements.
  • Clinical Documentation Management and industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations.
  • Experience with the following application types: Electronic documentation management systems, web-based data management systems, as required, and database utilization
  • Outstanding verbal and written communications skills, combined with outstanding listening skills are required. 
  • History of achievement in a customer service role with demonstration of meeting customer needs and concerns.
  • History of achievement in building strong customer relationships.  Strong skills in negotiation and conflict resolution essential. Ability to remain calm and focused in high-stress situations is very important. 
  • Strong background in provision of high levels of Customer Service evidenced by positive feedback from customers
Working Hours – 8am – 4pm EST
Travel Requirements - Ability to travel domestically within U.S. on average up to 10%

Why Work for Phlexglobal?
We offer challenging careers, projects, great benefits and a comprehensive and competitive rewards package, including great training and personalized career development opportunities.
Our benefits typically include a competitive base salary and generous annual leave. We also provide 401k, medical, dental and vision insurance.

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